Phase 4
Completed N=254
OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
Source: ClinicalTrials.gov NCT01945489 ↗Enrolled (actual)
254
Serious AEs
3.8%
Results posted
Nov 2017
Primary outcomePrimary: Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes — 32.0; 7.2 percentage of participants
◆ Published Evidence
Emerging
18citations · ~4 / year
Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial.
Summary
This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.
Linked Publications
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Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes |
32.0; 7.2 | — |
| PRIMARY Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence |
5.4; 5.9; -3.4; -1.7 | — |
| SECONDARY Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores |
52.38; 53.60; -21.98; -6.63; 42.91; 43.22 | — |
| SECONDARY Change From Baseline in the Daily Average Number of Micturition Episodes |
10.2; 11.1; -2.6; -1.3 | — |
| SECONDARY Change From Baseline in the Daily Average Number of Urgency Episodes |
4.9; 5.3; -3.3; -1.7 | — |
| SECONDARY Change From Baseline in the Daily Average Number of Nocturia Episodes |
2.2; 2.1; -0.7; -0.4 | — |
Eligibility Criteria
Inclusion Criteria
-Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.
Exclusion Criteria
- Symptoms of OAB due to a neurological reason
- Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening
- Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence
- Use of botulinum toxin therapy of any serotype for any urological condition
- Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening
- History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
- Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.
Data sourced from ClinicalTrials.gov (NCT01945489) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.